SBIR-STTR Award

Direct to Phase II

Minimally-invasive optical imaging is being advanced by molecular probes that enhance contrast usingfluorescence. The applications in cancer imaging are very broad, ranging from early diagnosis of cancer to theguiding of interventions, such as biopsy. The high-sensitivity afforded by wide-field fluorescence imaging usingscanning laser light is being developed for these broad applications. The platform technology is the SFE -Scanning Fiber Endoscope, which places a sub-1-mm scanner at the tip of a highly flexible shaft. Becauseseveral different laser wavelengths can be mixed and scanned together, full-color reflectance imaging will becombined with near infrared (NIR) fluorescence imaging in a 4-channel multimodal SFE. The goal of thisproject is to develop a prototype VerAvanti 4-channel multimodal SFE (mmSFE) for a specific cancer imagingapplication that can have significant impact in early detection and endoscopic treatment of esophageal cancer.VerAvanti is a start-up company located in Redmond, Washington and is founded and staffed with engineeringgraduates from the University of Washington (UW), where the SFE was invented and tested in pilot clinicaltrials. VerAvanti has exclusive license to commercialize the SFE technology for medical imaging and a 3-channel full color SFE (using red, green, and blue reflectance) is already in pilot manufacturing and testing.This project will rapidly translate the 4-channel mmSFE technology into a specific product for fluorescentlyguiding endoscopic interventions in the GI tract. Furthermore, the VerAvanti mmSFE will be designed forefficient manufacturing in a modular format with reduced part numbers and expected lower cost.The application is using NIR fluorescence molecular probes that were developed at the University of Michigan(UM) that bind to high grade dysplasia (HGD) and neoplastic cells of esophageal adenocarcinoma (EAC). ThemmSFE product is introduced through the working channel of a conventional endoscope to identify regions ofthe lower esophagus that are over-expressing EGFR and ErbB2, which are transmembrane tyrosine kinasereceptors that stimulate epithelial cell growth, proliferation, and differentiation. Overexpression of these targetsreflects an increase in biological aggressiveness and higher risk for progression to Barrett's esophagus, HGD,and EAC. The design of the mmSFE diagnostic algorithm is based on the high correlation of the fluorescencelesion target-to-background measurement in collaboration with UW and UM. Additional mmSFE guided toolswill be developed for more accurate endoscopic interventions using NIR fluorescence molecular probes. Bothsoftware and hardware will be fabricated and tested for the start of a multisite clinical trial using the mmSFE.

Public Health Relevance Statement:
The multimodal scanning fiber endoscope (mmSFE) technology was developed by the University of Washington, licensed to VerAvanti Inc., and now demonstrates feasibility for detecting early cancer of the esophagus in clinical testing at the University of Michigan using fluorescence molecular markers that bind to cancer cells. In this direct phase 2 SBIR project, VerAvanti will improve the fluorescence imaging performance of the prototype mmSFE system, support advanced imaging processing at the University of Washington, and design new interventional devices that provide direct visualization from an integrated mmSFE. The result of this project will be to provide a novel endoscope product to the University of Michigan and national leaders in the management of esophageal cancer for a future multisite clinical trial.

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